The randomized study of enteral nutrition with rapid versus conventional administration in acute stroke patients; the protocol of rapid EN trial

Kentaro Suzuki; Hidetaka Onodera; Rie Sugiyama; Seiji Okubo; Naoto Kimura; Shogo Kaku; Rieko Seki; Satoshi Fujita; Koichi Nomura; Taiki Takagiwa; Izumi Katafuchi; Homare Nakamura; Takuya Kanamaru; Momoyo Oda; Shohei Kimura; Shota Sonoda; Hiroto Kakita; Toshiaki Otsuka; Kazumi Kimura

doi:10.3389/fneur.2024.1393345

The randomized study of enteral nutrition with rapid versus conventional administration in acute stroke patients; the protocol of rapid EN trial

Front Neurol. 2024 Jun 3:15:1393345. doi: 10.3389/fneur.2024.1393345. eCollection 2024.

Authors

Kentaro Suzuki¹, Hidetaka Onodera², Rie Sugiyama³, Seiji Okubo⁴, Naoto Kimura⁵, Shogo Kaku⁶, Rieko Seki⁷, Satoshi Fujita⁸, Koichi Nomura⁹, Taiki Takagiwa¹⁰, Izumi Katafuchi¹⁰, Homare Nakamura¹¹, Takuya Kanamaru⁴, Momoyo Oda¹², Shohei Kimura⁶, Shota Sonoda⁶, Hiroto Kakita⁷, Toshiaki Otsuka¹³, Kazumi Kimura¹

Affiliations

¹ Department of Neurology, Nippon Medical School, Tokyo, Japan.
² Department of Neurosurgery, St. Marianna University School Toyoko Hospital, Kawasaki, Kanagawa, Japan.
³ Emergency and Critical Care Center, Nippon Medical School, Tokyo, Japan.
⁴ Department of Cerebrovascular Medicine, NTT Medical Center Tokyo, Tokyo, Japan.
⁵ Department of Neurosurgery, Iwate Prefectural Central Hospital, Morioka, Iwate, Japan.
⁶ Department of Neurosurgery, Neurosurgical East Yokohama Hospital, Yokohama, Kanagawa, Japan.
⁷ Department of Neurosurgery, Shimizu Hospital, Kyoto, Japan.
⁸ Department of Neurosurgery, Toho University Ohashi Medical Center, Tokyo, Japan.
⁹ Department of Neurology, Shioda Hospital, Chiba, Japan.
¹⁰ Stroke Care Unit, Nippon Medical School, Tokyo, Japan.
¹¹ Department of Neurosurgery, St. Marianna University Yokohama Seibu Hospital, Yokohama, Kanagawa, Japan.
¹² Department of Neurology, Iwate Prefectural Central Hospital, Morioka, Iwate, Japan.
¹³ Department of Public Health, Nippon Medical School, Tokyo, Japan.

Abstract

Rationale: Enteral nutrition is beneficial for stroke patients with oral intake difficulties. However, it is time consuming and may interfere with routine medical care. Therefore, there is a clinical benefit if enteral nutrition can be safely administered in a short time. Although our retrospective study showed the safety of rapid administration, it remains unclear whether rapid administration of enteral nutrition is as safe as conventional administration.

Aim: The randomized study of Enteral Nutrition with Rapid versus conventional administration in acute stroke patients (Rapid EN trial) aims to clarify the safety of rapid feeding of enteral nutrition compared with conventional feeding.

Methods and design: This is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded end-point clinical trial. Eligible criteria include acute stroke patients who have difficulty with oral intake defined as severe altered consciousness (Japan Coma Scale 10-300) or modified water swallowing test <4. The target enrollment is 700 patients, with 350 patients receiving rapid enteral nutrition at a rate of 100 mL in 5 min (Rapid EN group) and 350 patients receiving conventional enteral nutrition at a rate of 100 mL in 30 min (Conventional EN group).

Study outcome: The primary outcome is the incidence of one or more complications of vomiting or diarrhea or pneumonia within 7 days would be non-inferior in the rapid EN group compared to the conventional EN group. Secondary outcomes were total time spent on enteral nutrition within 7 days from enteral nutrition, the incidence of vomiting, diarrhea and pneumonia within 3 or 7 days, and the rate of favorable clinical outcome.

Discussion: Since no previous reports have focused on the speed of administration, we felt it was necessary to prove the safety of rapid administration. If this study shows positive results, it will not only benefit patients, but also reduce the burden of medical care. We believe this study is novel and will be useful in clinical practice.

Clinical trial registration: https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000046610 Identifier UMIN000046610.

Keywords: enteral feeding; enteral nutrition; rapid administration; speed; stroke.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was funded by JSPS Kakenhi Grants (Number 20K19651 to KS).